The Effect of Co Enzyme Q10 Together With Fertility Drugs on Pregnancy Outcome of in Vitro Fertilization (CoQ10-IVF)

This study has been terminated.

(A new study had shown that polar body biopsies might negatively effect the implantation potential of the embryo.)

Sponsor:

University of Toronto

ClinicalTrials.gov Identifier:

NCT01048385

First Posted: January 13, 2010

Last Update Posted: September 9, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The goal of our research is to increase live birth rates in infertile women and to reduce the incidence of aneuploidy leading to miscarriage and trisomies. We hypothesize that an age related mitochondrial dysfunction reduces the availability of energy in the oocyte and contributes to abnormal segregation of chromosomes during the meiotic division leading to oocyte aneuploidy. Based on preliminary evidence we have obtained in aged mice, we propose that dietary supplementation with Co enzyme Q10 in older women will improve mitochondrial function in the oocytes, leading to a decrease in chromosomal non-disjunction and resulting in embryos with a normal chromosomal complement. Our primary outcome measure will be determination of oocyte chromosome number by multiplex PCR based assay of polar bodies biopsied at the time of IVF. Outcomes of this proposal will enable us to address the mechanisms of ovarian aging and may explain etiology of decreased fertility in older patients. In addition, our work will add to the feasibility of single embryo transfer, thereby avoiding multiple pregnancies and their associated cost to the health care system and to society.

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Ages Eligible for Study:

35 Years to 43 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Age 35-43 years at the time of enrollment

Diagnosis of primary infertility

Exclusion Criteria:

Body mass index (BMI) > 38 kg/m2

Early follicular phase (day 2-4) serum FSH level > 20 mIU/ml.

Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography

Any current use of systemic steroid medication or any infertility treatment within 3 months of study enrollment.

Any contraindication to being pregnant and carrying a pregnancy to term.

Contraindication for the use of CoQ10, Superfact, Puregon, hCG, Estrace and Progesterone suppositories.

Any ovarian or abdominal abnormality that may interfere with adequate TVS evaluation.